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Vial Processing

SP Scientific’s PennTech manufactures advanced aseptic vial processing equipment that is uniquely engineered to outperform. A special emphasis is put on high quality, small scale, and efficient design principles. Today, SP PennTech is the only company in the United States to manufacture complete aseptic vial processing lines. Special emphasis is put on simplistic, yet robust design, adherence to cGMP guidelines, and quality, not only of the machines, but also of the supporting validation documents.

Vial Washers

The objective of vial washing is to remove particulate matter and microorganisms. Traditional vial washers employ moving parts (e.g., grippers with springs, penetrating spray needles, chains, moving rods) in the washing chamber, which all generate particulate matter. SP PennTech washers have only two moving parts inside the washing chamber and their main drive is servo-driven. They also cover the full range of pharmaceutical vials, from 2-100ml, both glass and plastic.

Each vial format has an HMI selected “recipe” with specific settings for such variables as spraying time and indexing time. Water for injection (WFI) can be recycled, filtered and used a second time and intermittent spraying further reduces water consumption. These factors result in a highly efficient vial washing process. For over 20 years, SP PennTech has optimized and perfected the art of vial washing.

Features- Typical batch size: 1,000-8,000 vials- 8 vial holders that hold up to 6 vials at the neck- A transparent cover permits visual verification of the washing process- Dedicated media manifolds (1 for water, 1 for air)- GMP design: All 304/316L stainless steel- Intrinsically designed for 3-log endotoxin reduction- Allen-Bradley Micrologix 1100 PLC that works in conjunction with an Allen-Bradley PanelView Component C400 Touch Terminal HMI- No penetrating nozzles, no glass breakage, less particulate generation- Self-draining after end of batch- Internal surfaces are electro polished- Orbital welding is used whenever possible- Piping system is designed to run from high to low to prevent water stagnation- Optional WFI-skid to supply the WFI at 80°C (no need for a WFI-loop)- Complete validation documents package available (FRS, DDS, FAT/SAT, IQ/OQ)

RW-500 Vial Washer

Dimensions : 133x128cm

Purpose : Smallest automatic vial washer and is designed for low-to-medium output pharmaceutical and biotech applications

Vial Range : 1-100ml (change parts required)

Output : Up to 120 vials per minute (dependent on the vial format)

Changeover : 20-minute changeover to a different vial format

Features- Typical batch size: 10,000-25,000 vials- 8 vial holders that hold up to 6 vials at the neck- Rotary infeed table with automatic loading of the vials into the vial holders- A transparent cover permits visual verification of the washing process- Dedicated media manifolds (1 for water, 1 for air)- Recycling of WFI, intermittent spraying and automatic lid lift mechanism- GMP design: All 304/316L stainless steel- Main drive is servo-driven- Intrinsically designed for 3-log endotoxin reduction- Allen-Bradley Micrologix 1100 PLC that works in conjunction with an Allen-Bradley PanelView 600+ operator interface- Each vial format has an HMI selected “recipe” with specific settings for spray time and indexing time to help reduce water consumption- Water for injection (WFI) can be recycled, filtered and used a second time, further reducing water consumption- No penetrating nozzles, no glass breakage, less particulate generation- Self-draining after end of batch- Internal surfaces are electro polished- Orbital welding is used whenever possible- Piping system is designed to run from high to low to prevent water stagnation- Silicone seals are used throughout the piping system- Optional WFI-skid to supply the WFI at 80°C (no need for a WFI-loop)- Complete validation documents package available (FRS, DDS, FAT/SAT, IQ/OQ)

RW-500TL Vial Washer with Integrated TrayloaderVial washing with automatic trayloading is made possible on the RW-500TL. An ideal batch vial processing system for low-to-medium volume output requirements. Vial range 2-100ml. Output up to 100 vials/minute. The trayloader does not require change parts. To maintain cleanliness, the outfeed of the washer and the trayloader can be placed under a Vertical Laminar Airflow Unit. Features include: "no-tray present, washer does not start-up" and "tray full, washer stops".

Features- Typical batch size: 10,000-25,000 vials- 8 vial holders that hold up to 6 vials at the neck- Vials are fed to the vial carriers by way of an infeed drive belt- Vials leave the washer in a single-file fashion- Rotary infeed table with automatic loading of the vials into the vial holders- A transparent cover permits visual verification of the washing process- Safety provisions are in place to prevent water spraying when the cover is not located over the washing chamber- Dedicated media manifolds (1 for water, 1 for air)- Recycling of WFI, intermittent spraying and automatic lid lift mechanism- cGMP design: All 304/316L stainless steel- Main drive is servo-driven- Intrinsically designed for 3-log endotoxin reduction- Allen-Bradley Micrologix 1100 PLC that works in conjunction with an Allen-Bradley PanelView 600+ operator interface- Each vial format has an HMI selected “recipe” with specific settings for spray time and indexing time to help reduce water consumption- Water for injection (WFI) can be recycled, filtered and used a second time, further reducing water consumption- No penetrating nozzles, no glass breakage, less particulate generation- Self-draining after end of batch- Internal surfaces are electro polished- Orbital welding is used whenever possible- Piping system is designed to run from high to low to prevent water stagnation- Silicone seals are used throughout the piping system- Optional WFI-skid to supply the WFI at 80°C (no need for a WFI-loop)- Complete validation documents package available (FRS, DDS, FAT/SAT, IQ/OQ)

Features- Typical batch size: 10,000-25,000 vials- 16 vial holders that hold vials at the neck- Vials are fed to the vial carriers by way of an infeed drive belt- Vials leave the washer in a single-file fashion- Rotary infeed table with automatic loading of the vials into the vial holders- Infeed Vial Flip Table that is ergonomically designed to avoid repetitive wrist motion, has a quicker plastic removal (2-3 times faster), and less potential of fallen vials- A transparent cover permits visual verification of the washing process- Safety provisions are in place to prevent water spraying when the cover is not located over the washing chamber- 14 effective water/air stations- Combined exposure time is approximately 20 seconds based on 30 indexes per minute- Dedicated media manifolds (1 for water, 1 for air)- Recycling of WFI, intermittent spraying and automatic lid lift mechanism- cGMP design: All 304/316L stainless steel- Main drive is servo-driven- Intrinsically designed for 3-log endotoxin reduction- Allen-Bradley Micrologix 1100 PLC that works in conjunction with an Allen-Bradley PanelView 600+ operator interface- Four level dual password protected menu guides the operator through the operations of the machine- Each vial format has an HMI selected “recipe” with specific settings for spray time and indexing time to help reduce water consumption- Water for injection (WFI) can be recycled, filtered and used a second time, further reducing water consumption- Tank includes a high and low level control mechanisms automatically adding water upon low-level detection- Internal immersion heating element helps maintain water temperature- No penetrating nozzles, no glass breakage, less particulate generation- Self-draining after end of batch- Internal surfaces are electro polished- Orbital welding is used whenever possible- Piping system is designed to run from high to low to prevent water stagnation- Silicone seals are used throughout the piping system- Optional WFI-skid to supply the WFI at 80°C (no need for a WFI-loop)- Complete validation documents package available (FRS, DDS, FAT/SAT, IQ/OQ)

Tunnel Loaders

SP PennTech offers a uniquely simple, yet effective, method of loading vials into the tunnel. The key here is to keep positive control over the vials at all times. Unlike “reverse funnels” and timing screws, vials are collected from the vial washer into a “pack” before gently being pushed into the tunnel by an oscillating pushing block. No format parts are required and the pushing motion is part of the vial recipe in the PLC. This is essentially a set-it-and-forget-it automatic process requiring no operator intervention.

CLICK HERE - Tunnel Loader Product Portfolio (TP-1 & TP-4)

TP-1 Tunnel Loader

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Dimensions : 180x40.6x96.5cm vial running surface 85-95cm

Purpose : A low-cost interface between the vial washer and the sterilizing tunnel

Vial Range : 2-500ml

Output : Up to 400 vials per minute

Changeover : No change parts required

Features- Suitable for sterilizing tunnels with a belt width of up to 600mm- Allows full access to the tunnel infeed area- Eliminates the “reverse tunnel” infeed method- Can be used with every “single-file-outfeed” vial washer

TP-4 Tunnel Loader

Dimensions : 210x66x96.5cm vial running surface 85-95cm

Purpose : A low-cost interface between the vial washer and the sterilizing tunnel

Vial Range : 2-500ml

Output : Up to 400 vials per minute

Changeover : No change parts required

Features- TP-4 row-by-row tunnel loader is designed for tunnels with belts- Row-by-row loading is the preferred method of loading larger sterilizing tunnels- Suitable for sterilizing tunnels with a belt width over 600mm- Tunnel belt movement can be synchronized with the TP-4 movement at vial format level- Optimum tunnel loading pattern without gaps in the vial pack, which contributes to an even heat distribution in the sterilizing chamber of the tunnel- PLC-controlled so that the loading speed and travel distance are automatically set per vial format- The vials are loaded in a nested pattern with the use of a servo motor- Eliminates the “reverse tunnel” infeed method- Virtually no glass-to-glass friction compared to the “reverse funnel” loading method- Will clear the dead plate at the end of the batch- Can be used with every “single-file-outfeed” vial washer

Sterilization Tunnels

The typical operating temperature of the tunnel is 320° C. At this temperature it takes 9.5 seconds to reduce the bacterial endotoxin level by 1-log. A 4-log reduction will take 38 seconds, and a 6-log reduction in bacterial endotoxin 57 seconds.

Heat is generated by silicon controlled rectifier (SCR) heating elements. Depending on the format, vials stay inside the sterilizing/depyrogenation chamber for approximately 6-10 minutes. The recirculated hot air is blown at a speed of approximately 0.7 m/s over the vials and remains within 2°C of its setpoint.

Features- SP PennTech is the only manufacturer of continuous processing tunnels in the United States- In fewer than 30 minutes, an untreated vial goes from vial washer to sterilizing tunnel to cleanroom, entering in a sterilized microorganisms- and pyrogen-free state- Requires no operator intervention or recontamination- Typical operating temperature of the tunnel is 320°C - At this temperature: - It takes 9.5 seconds to reduce the bacterial endotoxin level by 1-log - A 4-log reduction will take 38 seconds - A 6-log reduction in bacterial endotoxin 57 seconds- Heat is generated by silicon controlled rectifier (SCR) heating elements- Depending on the format, vials stay inside the sterilizing/depyrogenation chamber for approximately 6-10 minutes- The recirculated hot air is blown at a speed of approximately 0.7 m/s over the vials and remains within 2°C of its setpoint- Keeping control over the vials at all times, vials are fed from the vial washer via a sanitary conveyor before gently being pushed into the tunnel by an oscillating pusher- No format parts are required- This is essentially a set-it-and-forget-it automatic process- There are 3 chambers: pre-heating chamber, sterilizing chamber, and cooling chamber- Chambers of the tunnel are separated by gates and the height is automatically set by the PLC as part of the vial recipe- HEPA filters are tested for efficiency by the “DOP” test procedure (each chamber of the tunnel has provisions to conduct the DOP test)- Each chamber is equipped with a pipe below the filters to allow for particle counting

Aseptic Fillers

The FS(C)-series is comprised of single and dual filling and stopper-inserting machines, with or without the capping function, and is designed for 2ml to 100ml vials and offers an output of up to 200 vials per minute. The compact in-line design features Allen Bradley components and is equipped with servo-motors. Format changeovers are highly automated using PLC-stored recipes per vial format.

Purpose : Designed for aseptic applications in a class-100 environment

Vial Range : 2-100ml

Output : Up to 25 vials per minute

Changeover : Automated, recipe-driven format changeover

Features- 1-up intermittent-motion filling, stoppering and capping system- 1 filling nozzle, a stopper inserting station and a crimping head for aluminum caps- Equipped with an Allen Bradley PLC and HMI- Highest precision and most advanced pumps that are driven by PLC-controlled individual servo motors- Rollers are positively driven, substantially increasing the longevity of the tubing, hence maintaining the fill accuracy- Drip-free filling is an inherent feature- Gamma sterilized, disposable filling systems are available- Rotary piston pumps are constructed from a single piece of 316 stainless steel- High precision seal-less and hard-coated matching sets provide high accuracy and repeatability throughout the entire batch- Format changeovers are highly automated using PLC-stored recipes per vial format- Optional load cells can be installed for net weight filling- Vial transport belt places the vials onto the load cells in such a fashion that the vials are free-standing without touching the transport belt- Bottom-up filling (90% will be dispensed at “high” speed and 10% at “low” speed)- Optional pre- and post-gas flushing- Stoppers and caps: 13mm and 20mm- Bulk hoppers with level control- All stainless steel construction- O-RABS and C-RABS optional- Comprehensive equipment documentation with exploded 3-D assembly drawings- Complete validation documents package available (FRS, DDS, FAT/SAT, IQ/OQ)

Capping Machine

SP PennTech capping machines feature all stainless steel construction with tempered glass doors and windows and stainless steel hinges with built-in safety switches. Their sanitary, raised track conveyor makes cleaning easy. No stopper, no cap pick up. There is a reject station available. The compact and versatile design features the electrical cabinet located within the frame of the machine and 13, 20 and 32mm flip-off caps with PLC-assisted changeover and a menu-driven operation through AB PLC and AB PanelView 1000 Plus.

External Vial Washers

Vials filled with potent drugs such as antibiotics, cytotoxics and cytostatics need to be cleaned before further processing. SP PennTech’s unique solution to this requirement is achieved by enclosing the aluminum cap between two opposed belts. The seal that is created prevents the cleaning agent from entering the cap area, thereby eliminating potential future bacterial contamination.

Another advantage of sealing the cap is the application of pressurized water for cleaning the entire vial body, including the bottom. Operation is menu-driven through the human machine interface (HMI). PLC-controlled servo motors automatically set the output rate, the vial height and the water/air flow per vial size. The changeover to a different cap or vial format is tool-less and can be accomplished within 15 minutes.

Changeover : Less than 20 minutes (tool-less and the only change part is the vial transport timing screw)

Features- Can be used as a stand-alone unit with an infeed and outfeed turntable or integrated into a filling line- No alignments of spray nozzles- No format parts required for 13 and 20mm caps- Equipped as standard with an Allen Bradley CompactLogix PLC and an Allen Bradley PanelView 600 Plus Human Machine Interface (HMI) - Siemens is available as an option- Menu-driven operation through the human machine interface (HMI)- PLC-controlled servo motors automatically set the output rate, the vial height and the water/air flow per vial size- All electrical components are installed in the electrical cabinet located in the base of the machine- Piping system and electrical cabinet are installed inside the frame of the machine, resulting in a small footprint and a clean installation- A vial-dedicated timing screw over the length of the machine captivates and transports the vial through the machine- The vials ride on a narrow rail and rotate continuously during their travel in the machine- Enclosing the aluminum cap between two opposed belts creates a seal that prevents the cleaning agent from entering the cap area and allows pressurized water for cleaning the entire vial body, including the bottom- The machine is separated into the rinsing section and the drying section- Rinsing is accomplished by low pressure water nozzles, cleaning the vials from the neck down (while they rotate)- Drying can be accomplished by either compressed facility air or by an on-board air blower in the base of the machine- Vials leave the machine dry- Optional negative pressure can be obtained in the enclosure by installing an exhaust with HEPA-filter on the top of the unit- Glove ports can be installed in the doors- All stainless steel, heavy duty construction with tempered glass windows and doors

Changeover : 5 minutes (tool-less and the only change part is the vial transport timing screw)

Features- Can be used as a stand-alone unit with an infeed and outfeed turntable or integrated into a filling line- No alignments of spray nozzles- No format parts required for 13 and 20mm caps- Fresh Water Rinsing, Compressed Air Drying- Equipped as standard with an Allen Bradley CompactLogix PLC and an Allen Bradley PanelView 600 Plus Human Machine Interface (HMI) - Siemens is available as an option- Menu-driven operation through the human machine interface (HMI)- To avoid unauthorized access to machine functions password levels are implemented- PLC-controlled servo motors automatically set the output rate, the vial height and the water/air flow per vial size- All electrical components are installed in the electrical cabinet located in the base of the machine- Piping system and electrical cabinet are installed inside the frame of the machine, resulting in a small footprint and a clean installation- A vial-dedicated timing screw over the length of the machine captivates and transports the vial through the machine- The vials ride on a narrow rail and rotate continuously during their travel in the machine- Enclosing the aluminum cap between two opposed belts creates a seal that prevents the cleaning agent from entering the cap area and allows pressurized water for cleaning the entire vial body, including the bottom- The machine is separated into the rinsing section and the drying section- Rinsing is accomplished by low pressure water nozzles, cleaning the vials from the neck down (while they rotate)- Drying can be accomplished by either compressed facility air or by an on-board air blower in the base of the machine- Vials leave the machine dry- Optional negative pressure can be obtained in the enclosure by installing an exhaust with HEPA-filter on the top of the unit- An accident prevention hood or under pressurized hood with gloves ports is available- All stainless steel, heavy duty construction with tempered glass windows and doors

Changeover : 5 minutes (tool-less and the only change part is the vial transport timing screw)

Features- Can be used as a stand-alone unit with an infeed and outfeed turntable or integrated into a filling line- Separate drying stem is required to assure bone-dry vials when exiting the decontamination machine- No alignments of spray nozzles- No format parts required for 13 and 20mm caps- Equipped as standard with an Allen Bradley CompactLogix PLC and an Allen Bradley PanelView 600 Plus Human Machine Interface (HMI) - Siemens is available as an option- Menu-driven operation through the human machine interface (HMI)- To avoid unauthorized access to machine functions password levels are implemented- PLC-controlled servo motors automatically set the output rate, the vial height and the water/air flow per vial size- All electrical components are installed in the electrical cabinet located in the base of the machine- Piping system and electrical cabinet are installed inside the frame of the machine, resulting in a small footprint and a clean installation- A vial-dedicated timing screw over the length of the machine captivates and transports the vial through the machine- The vials ride on a narrow rail and rotate continuously during their travel in the machine- Enclosing the aluminum cap between two opposed belts creates a seal that prevents the cleaning agent from entering the cap area and allows pressurized water for cleaning the entire vial body, including the bottom- The machine is separated into the rinsing section and the drying section- Rinsing is accomplished by low pressure water nozzles, cleaning the vials from the neck down (while they rotate)- Drying can be accomplished by either compressed facility air or by an on-board air blower in the base of the machine- Optional negative pressure can be obtained in the enclosure by installing an exhaust with HEPA-filter on the top of the unit- An accident prevention hood or under pressurized hood with gloves ports is available- All stainless steel, heavy duty construction with tempered glass windows and doors

Lyophilizer Loading Equipment

Lyophilizer Loading Equipment features consistent loading with the same number of vials per tray, and non-stop loading, even when replacing a full tray. Automatic containment ring lowering systems for freeze drying applications and camera inspection to ensure same cap color/format and vial configuration options are available.

CLICK HERE - Lyophilizer Loading Equipment Product Portfolio

Automatic Loading and Unloading System

Dimensions : To be determined - vial running surface 85-95cm

Purpose : Fully automatic loading and unloading of vials onto a freeze dryer shelf within an isolator or RABS

Vial Range : 2-100ml

Output : Up to 400 vials per minute

Changeover : To be determined

Features- Can be installed as part of a new freeze dryer installation and as retrofit with almost all existing freeze dryers- Can serve single or multiple freeze dryers on either side of the cleanroom- Even freeze dryers with different loading height can be loaded and unloaded by the same system- Choice of systems (the choice is governed by the line layout) - Infeed Station + fixed AGV* + Outfeed Station - Infeed Station + rotating AGV + Outfeed Station - Infeed/Outfeed Station + fixed AGV - Infeed/Outfeed Station + rotating AGV- Each system can be equipped with: - Laminar Air Flow units (LAF) - Open Restricted Access Barrier System (o-RABS) - Closed Restricted Access Barrier System (c-RABS) - Isolator

Trayloaders

If vial collection is required, SP PennTech has customized trayloaders for your application and your tray format. They offer a single trayloader up to 200 vials/minute or a dual trayloader up to 400 vials/ minute with a vial range from 2-500ml vials/bottles. No format/change parts are required. The trayloaders are menu-driven with a PLC-assisted changeover and feature automatic nesting.

CLICK HERE - Trayloaders Product Portfolio (TL-100 / 200)

TL - 100

Dimensions : 208x112x95cm vial running surface 85-95cm

Purpose : Designed to collect vials for your application and your tray format

Vial Range : 2-500ml

Output : Up to 200 vials per minute (depending on vial diameter and tray size)

Changeover : 2 minutes (tool-less)

Features- Single trayloader- Controlled by a Programmable Logic Controller (PLC) and will handle plastic and glass vials- Designed to handle trays up to 610 mm (24") wide (open end) and up to 610 mm (24") deep- Tray materials can be metal, cardboard, corrugated plastic, or rigid plastic- No format/change parts required- Menu-driven, PLC-assisted changeover- Automatic nesting- Optional automatic containment ring lowering system for freeze drying applications- Optional camera inspection to ensure same cap color/format and vial configuration- Consistency in trayloading, always the same number of vials per tray- Non-stop loading, even when replacing a full tray

TL - 200

Dimensions : 297.5x112x95cm vial running surface 85-95cm

Purpose : Designed to collect vials for your application and your tray format

Vial Range : 2-500ml

Output : Up to 400 vials per minute (depending on vial diameter and tray size)

Changeover : 2 minutes (tool-less)

Features- Dual trayloader- Controlled by a Programmable Logic Controller (PLC) and will handle plastic and glass vials- Designed to handle trays up to 610 mm (24") wide (open end) and up to 610 mm (24") deep- Tray materials can be metal, cardboard, corrugated plastic, or rigid plastic- No format/change parts required- Menu-driven, PLC-assisted changeover- Automatic nesting- Optional automatic containment ring lowering system for freeze drying applications- Optional camera inspection to ensure same cap color/format and vial configuration- Consistency in trayloading, always the same number of vials per tray- Non-stop loading, even when replacing a full tray

CLICK HERE - Trayloaders Product Portfolio (HSTL-200)

HSTL - 200

Dimensions : 297.5x97x100cm vial running surface 85-95cm

Purpose : Designed to collect vials for your application and your tray format

Vial Range : 2-500ml

Output : Up to 500 vials per minute (depending on vial diameter and tray size)

Changeover : 2 minutes (tool-less)

Features- Dual trayloader- Controlled by a Programmable Logic Controller (PLC) and will handle plastic and glass vials- Designed to handle trays up to 610 mm (24") wide (open end) and up to 610 mm (24") deep- Tray materials can be metal, cardboard, corrugated plastic, or rigid plastic- No format/change parts required- Menu-driven, PLC-assisted changeover- Automatic nesting- Optional automatic containment ring lowering system for freeze drying applications- Optional camera inspection to ensure same cap color/format and vial configuration- Consistency in trayloading, always the same number of vials per tray- Non-stop loading, even when replacing a full tray

Peripheral Equipment

To integrate your aseptic filling line you will need peripheral equipment, such as: a Multi-Lane Accumulating Table, a Sanitary Raised-Track Conveyor, a Through-The-Wall Conveyor, a Down-Vial Reject Block, a Rotary Accumulating and Transfer Table, a Side-By-Side Conveyor Transfer, or a Vial Inverting Table.